Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.

What this trial studies

The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) to preliminary assess safety and effectivity of a novel hormone-free mucosa composition (XCMIM20m) applied topically to the vulvovaginal area. Symptoms of vaginal atrophy will be compared before and after 8 weeks of use of the tested gel with the Day-to-Day Impact of Vaginal Aging (DIVA) PROMs questionnaire to assess changes impact of GSM symptoms.

Conditions in scope

• Vulvar Atrophy
• Vulvovaginal Signs and Symptoms
• Genitourinary Syndrome of Menopause
• Quality of Life
• Menopause Related Conditions
• Dyspareunia
• Urinary Incontinence, Urgency-frequency
• Sexual Function

Interventions

• Hormone-free vulvovaginal gel with the tested composition XCMIM20m (Device) — Management of GSM in post-menopausal women will be measured with the combination of the application of the hormone-free vulvovaginal gel along the 8 weeks of the study and the use of a PROMs questionnaire. PROMS questionnaire will be delivered to…

Who can join

Women only · Ages 40 Years to 70 Years

Inclusion criteria

• Patient has to have at least one symptom of GSM or suffer from symptoms related to vulvovaginal atrophy (as evidenced by gynecological examination with a Vaginal Health Index ≤15).
• Patient must be postmenopausal with at least 1 year without a menstrual period.
• Patient must consider that her quality of life is affected by GSM symptoms
• Patient not followed due to any gynecological disease.
• All participants must be able to understand and to fill in the self-reported questionnaires.

Exclusion criteria

• Patients that do not want to fill the questionnaire, especially the questions that address sexual functioning.
• Participants that use any oral products containing hormones or estrogen receptor modulators for the past 8 weeks, nor vaginal topical hormone products within 4 weeks, neither prescription nor non-prescription therapies for GSM, including topical vaginal non-hormonal lubricants or moisturizers for the last week.
• Patients with history of vulvar, vaginal and/or cervical malignancy.
• Patients having received radiotherapy treatment in the pelvic and/or genital region.
• Patients with any type of disease that causes alteration of collagenogenesis.
• Patients that use cytotoxic drugs leading to mucositis and alterations of tissue regeneration in the last 6 months.
• Patients having received laser and/or radiofrequency treatment for handling genital atrophy or other pelvic floor dysfunctions.
• Patients with active urinary and/or genital tract infection.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2024-01-08
• Primary completion: 2026-12
• Last update posted: 2026-03-30
• First posted: 2025-05-08

Sponsor & contact

Lead sponsor: Mucosa Innovations, S.L. (Industry)

Collaborators: Hospital de La Luz, Hospital Universitario Fundación Jiménez Díaz

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Changes in GSM symptoms impact on quality of life domains after the intervention (Eight weeks of use of the tested product.)
  Difference of magnitude of complaint by domain after 8 weeks of use of the tested product compared with baseline with the use of the PROMs questionnaire. The PROMs questionnaire will be the 23-item DIVA questionnaire comprising four domain scales: activities of daily living; emotional well-being; sexual functioning; and self-concept and body image. Each 23 items will be scored from 0…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.